Effect of Celecoxib and Etoricoxib on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
Tramadol is an opioid analgesic, which is widely used in the treatment of acute and
neuropathic pain. After oral administration, tramadol is rapidly and almost completely
absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed
by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation
is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral
tramadol with selecoxib and etoricoxib. Selecoxib is known to inhibit CYP2D6. Twelve healthy
male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of
the ideal weight for height are taken into the study. Primary endpoints of the study are
plasma concentrations of tramadol and its metabolites.